Device recall
Z-1841-2020: Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50…
FDA device recall · Class II · Philips Ultrasound Inc
Key facts
| Recall number (Z-number) | Z-1841-2020 |
|---|---|
| Recall event | 84902 |
| Product | Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies |
| Product code | ITX |
| Recalling firm | Philips Ultrasound Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2024 |
| 510(k) numbers | K160807, K162329 |
| FEI number | 3019216 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database